Once daily dose of Amikacin versus twice daily dose for treatment of early onset neonatal sepsis

Not Applicable

• Conditions: eonatal sepsis.; P36.8

• Registration Number: IRCT201112248507N1
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Term Infants with the clinical signs of sepsis in premature newborn infants admitted Bou Ali Sina Hospital of Sari treated with Ampicillin plus Amikacin.
Exclusion criteria : fetal age more than 42 Weeks and less than 37 weeks; Low birth weight; having congenital heart disease and asphyxia; not treated with Ampicillin and Amikacin at the age of 7 days; renal and hearing congenital disorders; prescription medications that have toxic effect on renal and auditory systems; neonatal meningitis; pathologic icter and TORCH Infections.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The treatment of SDL peak in therapeutic range. Timepoint: Sixty minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30. Method of measurement: Serum samples.;The treatment of through SDL in non-toxic range. Timepoint: Sixty minutes after intramuscular administration or 30 minutes after intravenous administration in the range 15 -30. Method of measurement: Serum samples.

Secondary Outcome Measures

Name	Time	Method
Potential renal side effects. Timepoint: Before the next dose. Method of measurement: Serum samples.;Potential hearing side effects. Timepoint: Before the Next Dose. Method of measurement: Auditory brainstem response and audiometry.